LUMINELLE DTx System

K210512 · Uvision360, Inc. · FAJ · Jun 30, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K210512
• Device Name: LUMINELLE DTx System
• Applicant: Uvision360, Inc.
• Product Code: FAJ · Gastroenterology, Urology
• Decision Date: Jun 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Hysteroscopy: The LUMINELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures. Generally recognized indications for diagnostic hysteroscopy include: Abnormal bleeding; Infertility and pregnancy wastage; Evaluation of abnormal hysterosalpingogram; Intrauterine foreign body; Amenorrhea; Pelvic pain. Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy; Polypectomy; Submucous myomectomy; Transection of intrauterine adhesions; Transection of intrauterine septa; Endometrial ablation. Cystoscopy: The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures. NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Device Story

LUMINELLE DTx System is an endoscopic visualization system for hysteroscopy and cystoscopy. Input: optical images from the cervical canal, uterine cavity, or lower urinary tract via a reusable scope. Transformation: scope transmits images to a Control Hub, which acts as an image converter and visualization interface for display on a standard HD monitor. Output: real-time video feed for physician viewing. Used in hospitals and physician offices by clinicians. The system supports diagnostic and surgical procedures; specific disposable sheaths (Diagnostic or Biopsy) limit the system to diagnostic-only use. The new Bx 360° Rotatable Disposable Sheath allows for biopsy via syringe aspiration. The device benefits patients by enabling minimally invasive visualization and tissue sampling for gynecological and urological conditions.

Clinical Evidence

No clinical data. Bench testing only. Included design verification/validation, usability testing per IEC 62366-1/ANSI/AAMI HE75 in simulated models, reprocessing validation, biocompatibility per ISO 10993, electrical safety/EMC per IEC 60601 series, and shelf-life/distribution testing per ASTM standards.

Technological Characteristics

System includes reusable scope, communication cable, and control hub. Sheaths use PEEK (flexible) or 304 stainless steel (rigid). Imaging via CMOS chip (400x400 pixels). Power: 120V AC to 12V DC conversion. Connectivity: HDMI/USB for monitor/computer. Sterilization: Ethylene Oxide (EO) or V-PRO Low Temperature. Disinfection: 0.6% OPA or Steris Revital-Ox RESERT. Standards: ISO 10993, IEC 60601-1, IEC 60601-2-18, ISO 8600 series.

Indications for Use

Indicated for patients requiring diagnostic or surgical hysteroscopy (e.g., abnormal bleeding, infertility, pelvic pain) or endoscopic access/examination of the lower urinary tract/bladder. Biopsy sheath indicated for endometrial or lower urinary tract biopsy via aspiration.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• LUMINELLE DTx Hysteroscopy System (K192278)

Submission Summary (Full Text)

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June 30, 2021

UVision360, Inc. % Rita King CEO and Senior Consultant MethodSense, Inc. 1 Copley Pkwy, Ste. 410 Morrisville, NC 27560

Re: K210512

> Trade/Device Name: LUMINELLE DTx System Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH, FAJ, HFF, FCK Dated: June 1, 2021 Received: June 2, 2021

Dear Rita King:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210512

Device Name LUMINELLE DTx System

#### Indications for Use (Describe)

#### Hysteroscopy:

The LUMNELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Generally recognized indications for diagnostic hysteroscopy include:

- Abnormal bleeding
- · Infertility and pregnancy wastage
- · Evaluation of abnormal hysterosalpingogram
- · Intrauterine foreign body
- · Amenorrhea
- · Pelvic pain

Generally recognized indications for use for operative hysteroscopy include:

- · Directed endometrial biopsy
- · Polypectomy
- Submucous myomectomy
- · Transection of intrauterine adhesions
- · Transection of intrauterine septa
- · Endometrial ablation

#### Cystoscopy:

The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.

NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

| Submitter: | UVision360 Inc.<br>158 Wind Chime Ct.<br>Suite 201<br>Raleigh, NC 27615<br>Phone: [phone] |
|----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact: | Rita King, CEO<br>MethodSense, Inc.<br>Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Company Contact: | Allison London Brown<br>CEO |
| Date Prepared: | June 1, 2021 |
| Device Name and Classification | |
| Trade Name:<br>Common Name:<br>Classification:<br>Regulation Number: | LUMINELLE DTx System<br>Hysteroscope and accessories, Endoscope and accessories<br>Class II<br>21 CFR 884.1690 Hysteroscope and accessories<br>21 CFR 876.1500 Endoscope and accessories<br>21 CFR 884.1060 Endometrial Aspirator<br>21 CFR 876.1075 Gastroenterology-urology biopsy instrument |
| Classification Panel: | Obstetrics/Gynecology<br>Gastroenterology/Urology |
| Product Code: | HIH Hysteroscope (And Accessories)<br>FAJ Cystoscope And Accessories; Flexible/Rigid<br>HFF Aspirator, Endometrial<br>FCK Instrument, Biopsy, Suction |

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| | Predicate Device |
|---------------------------|-------------------------------------------------------------------------------------------|
| Trade Name | LUMINELLE DTx System |
| Common Name | Hysteroscope (and accessories); Cystoscope<br>(and accessories) |
| 510(k) Submitter / Holder | UVision360 Inc. |
| 510(k) Number | K192278 |
| Regulation Number | 21 CFR 884.1690 Hysteroscope and accessories<br>21 CFR 876.1500 Endoscope and accessories |
| Classification Panel | Gastroenterology/Urology<br>Obstetrics/Gynecology |
| Product Code | HIH Hysteroscope (And Accessories)<br>FAJ Cystoscope And Accessories; Flexible/Rigid |

Predicate Device:

The predicate device has not been subject to a design-related recall.

#### Device Description

The LUMINELLE DTx System, previously known as the LUMINELLE DTx Hysteroscope System, originally received 510(k) clearance in 2018 as a hysteroscopic system (K181909). In addition, LUMINELLE DTx Hysteroscopy System received 510(k) clearance in 2019 for the addition of a sheath component, LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid to the system (K190827) and LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) (K19227).

The LUMINELLE DTx System permits viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures. The LUMINELLE DTx System is intended for use in endoscopic access to the examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the LUMINELLE DTx System allows the user to perform various diagnostic and therapeutic procedures.

The LUMINELLE DTx System is comprised of the following components:

- LUMINELLE DTx Scope;
- . LUMINELLE Communication Cable;
- LUMINELLE Control Hub: ●
- USB cable: .
- HDMI cable, and;
- power cord.

UVision360, Inc. (hereafter UVision360) designed a new accessory, the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) that is compatible with the LUMINELLE DTx System that permits direct viewing of the cervical canal and uterine cavity during biopsy procedures. LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy) is a single use accessory and is made of the same materials as the previously cleared sheaths (K190827, K192278).

The LUMINELLE DTx Scope is reprocessed after each use, depending on the procedure. High Level Disinfection (HLD) solutions can be used to reprocess the LUMINELLE DTx Scope when used with a cystoscopy procedure. 0.6% Ortho-Phthalaldehyde (OPA), a chemical disinfectant, has been previously cleared for HLD. However, UVision360 has verified and validated an additional chemical, Steris Revital-Ox™ RESERT® High Level Disinfectant, for HLD with the LUMINELLE DTx System. Steris Revital

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Ox™ RESERT® High Level Disinfectant has been tested in order to determine that it identically cleans the LUMINELLE DTx Scope as 0.6% OPA and does not adversely affect the functionality of the LUMINELLE DTx System.

Before a hysteroscope procedure, the LUMINELLE DTx Scope must be sterilized to be reprocessed. In the previous submissions, Ethylene Oxide, qualified by Andersen Scientific, Inc., has been used to sterilize the LUMINELLE DTx Scope. An additional sterilization method, V-PRO® Low Temperature Sterilization, qualified by Steris located in Mentor, OH, has been validated and verified as an additional sterilization method to ensure that it properly sterilizes the LUMINELLE DTx Scope.

### Indications for Use

Hysteroscopy:

The LUMINELLE DTx System is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

NOTE: Hysteroscopes are used as tools to access the uterine cavity and are not. in and of themselves, a method of surgery. When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 3600 Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

Generally recognized indications for diagnostic hysteroscopy include:

- Abnormal bleeding
- . Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain ●

Generally recognized indications for use for operative hysteroscopy include:

- Directed endometrial biopsy .
- . Polypectomy
- Submucous myomectomy
- Transection of intrauterine adhesions ●
- Transection of intrauterine septa
- . Endometrial ablation

# Cystoscopy:

The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.

NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only.

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NOTE: When the LUMINELLE DTx System is used with the LUMINELLE Bx 360° Rotatable Disposable Sheath (Biopsy), the system is limited to performing diagnostic procedures only. The Bx Sheath can be used for endometrial or lower urinary tract (including bladder) biopsy by aspiration with a syringe during diagnostic procedures.

#### Substantial Equivalence

The table below provides a detailed comparison of the LUMINELLE DTx System to the predicate device.

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# Detailed Comparison of the Subject and Predicate Devices

| Item | Subject Device | Predicate Device | Comparison |
|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| Indications for<br>Use | Hysteroscopy:<br>The LUMINELLE DTx System is used to permit<br>viewing of the cervical canal and uterine cavity for<br>the purpose of performing diagnostic and surgical<br>procedures.<br><br>NOTE: Hysteroscopes are used as tools to access<br>the uterine cavity and are not, in and of themselves,<br>a method of surgery. When LUMINELLE DTx<br>System is specifically used with the LUMINELLE<br>Dx 360° Rotatable Disposable Sheath (Diagnostic),<br>the system is limited to performing diagnostic<br>procedures only. When the LUMINELLE DTx<br>System is used with the LUMINELLE Bx 360°<br>Rotatable Disposable Sheath (Biopsy), the system is<br>limited to performing diagnostic procedures only.<br>The Bx Sheath can be used for endometrial or lower<br>urinary tract (including bladder) biopsy by<br>aspiration with a syringe during diagnostic<br>procedures.<br><br>Generally recognized indications for diagnostic<br>hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal<br>hysterosalpingogram | Hysteroscopy:<br>The LUMINELLE DTx Hysteroscopy System is<br>used to permit viewing of the cervical canal and<br>uterine cavity for the purpose of performing<br>diagnostic and surgical procedures.<br><br>NOTE: Hysteroscopes are used as tools to<br>access the uterine cavity and are not, in and of<br>themselves, a method of surgery. When<br>LUMINELLE DTx Hysteroscopy System is<br>specifically used with the LUMINELLE Dx 360°<br>Rotatable Disposable Sheath (Diagnostic), the<br>system is limited to performing diagnostic<br>procedures only<br><br>Generally recognized indications for diagnostic<br>hysteroscopy include:<br>• Abnormal bleeding<br>• Infertility and pregnancy wastage<br>• Evaluation of abnormal<br>hysterosalpingogram<br>• Intrauterine foreign body<br>• Amenorrhea<br>• Pelvic Pain<br><br>Generally recognized indications for use for<br>operative hysteroscopy include: | The Indications for Use of the<br>LUMINELLE DTx System is<br>the same as the Indications for<br>Use of the primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | Intrauterine foreign body Amenorrhea Pelvic pain Generally recognized indications for use for operative hysteroscopy include: Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy:<br>The LUMINELLE DTx System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.<br>NOTE: When LUMINELLE DTx System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | Directed endometrial biopsy Polypectomy Submucous myomectomy Transection of intrauterine adhesions Transection of intrauterine septa Endometrial ablation Cystoscopy: The LUMINELLE DTx Hysteroscopy System is intended for use in endoscopic access to and examination of the lower urinary tract, including the bladder. When combined with accessory instruments, the System allows the user to perform various diagnostic and therapeutic procedures.<br>NOTE: When LUMINELLE DTx Hysteroscopy System is specifically used with the LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic), the system is limited to performing diagnostic procedures only. | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | NOTE: When the LUMINELLE DTx System is<br>used with the LUMINELLE Bx 360° Rotatable<br>Disposable Sheath (Biopsy), the system is limited to<br>performing diagnostic procedures only. The Bx<br>Sheath can be used for endometrial or lower urinary<br>tract (including bladder) biopsy by aspiration with a<br>syringe during diagnostic procedures. | | |
| Intended Use | Hysteroscopy Intended Use:<br>The LUMINELLE DTx System is used to permit<br>direct viewing of the cervical canal and uterine<br>cavity for the purpose of performing diagnostic and<br>surgical procedures.<br>NOTE: When LUMINELLE DTx System is<br>specifically used with the LUMINELLE Dx 360°<br>Rotatable Disposable Sheath (Diagnostic), the<br>system is limited to performing diagnostic<br>procedures only. | Hysteroscopy Intended Use:<br>The LUMINELLE DTx Hysteroscopy System is<br>used to permit direct viewing of the cervical<br>canal and uterine cavity for the purpose of<br>performing diagnostic and surgical procedures.<br>NOTE: When LUMINELLE DTx Hysteroscopy<br>System is specifically used with the<br>LUMINELLE Dx 360° Rotatable Disposable<br>Sheath (Diagnostic), the system is limited to<br>performing diagnostic procedures only. | The Intended Use of the<br>LUMINELLE DTx System is<br>the same as the Intended Use of<br>the Primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| | Cystoscopy Intended Use:<br>The LUMINELLE DTx System is intended for use<br>in endoscopic access to the examination of the lower<br>urinary tract, including the bladder. When combined<br>with accessory instruments, the System allows the<br>user to perform various diagnostic and therapeutic<br>procedures. | Cystoscopy Intended Use:<br>The LUMINELLE DTx Hysteroscopy System is<br>intended for use in endoscopic access to the<br>examination of the lower urinary tract, including<br>the bladder. When combined with accessory<br>instruments, the System allows the user to<br>perform various diagnostic and therapeutic<br>procedures. | |
| | NOTE: When LUMINELLE DTx System is<br>specifically used with the LUMINELLE Dx 360°<br>Rotatable Disposable Sheath (Diagnostic), the | NOTE: When LUMINELLE DTx Hysteroscopy<br>System is specifically used with the<br>LUMINELLE Dx 360° Rotatable Disposable | |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | system is limited to performing diagnostic<br>procedures only. | Sheath (Diagnostic), the system is limited to<br>performing diagnostic procedures only. | |
| | NOTE: When the LUMINELLE DTx System is<br>used with the LUMINELLE Bx 360° Rotatable<br>Disposable Sheath (Biopsy), the system is limited to<br>performing diagnostic procedures only. The Bx<br>Sheath can be used for endometrial or lower urinary<br>tract (including bladder) biopsy by aspiration with a<br>syringe during diagnostic procedures. | | |
| Product Code | HIH (Hysteroscope and Accessories)<br>FAJ (Cystoscope and Accessories) | HIH (Hysteroscope and Accessories)<br>FAJ (Cystoscope and Accessories) | The Product Codes of the<br>LUMINELLE DTx System are<br>identical to the product codes of<br>the primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| Patient<br>Contacting<br>Materials<br>(Biocompatibility<br>) | ISO 10993 Compliant | ISO 10993 Compliant | The biocompatibility compliance<br>of patient contacting materials of<br>the LUMINELLE DTx System<br>is identical to the compliance of<br>the primary predicate,<br>LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). |
| Components | ● LUMINELLE DTx Hysteroscope<br>● LUMINELLE DTx 360° Rotatable<br>Disposable Sheath | ● LUMINELLE DTx Hysteroscope<br>● LUMINELLE DTx 360° Rotatable<br>Disposable Sheath | The main components of the<br>LUMINELLE DTx System are<br>identical to the main components<br>of the primary predicate |
| Item | Subject Device | Predicate Device | Comparison |
| | LUMINELLE DTx System | LUMINELLE DTx Hysteroscopy System<br>(K192278) | |
| | LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) LUMINELLE Bx 360° Rotatable Disposable Sheath (Sheath) | LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid LUMINELLE Communication Cable LUMINELLE Control Hub LUMINELLE Dx 360° Rotatable Disposable Sheath (Diagnostic) | LUMINELLE DTx<br>Hysteroscopy System<br>(K192278). The only difference<br>is the addition of a new<br>accessory, LUMINELLE Bx<br>360° Rotatable Disposable<br>Sheath (Biopsy). This difference<br>does not affect the safety and<br>effectiveness of the device as<br>validation and verification has<br>been performed on the new<br>sheath. |
| Rigid/Flexible<br>Sheath | Flexible and rigid sheaths available:<br>Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a PEEK<br>(polyetheretherketone) hypotube for flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid,<br>LUMINELLE Dx 360° Rotatable Disposable<br>Sheath (Diagnostic) and LUMINELLE Bx 360°<br>Rotatable Disposable Biopsy Sheath) contains a<br>304 stainless steel inner tube for rigidity. | Flexible and rigid sheaths available:<br>Flexible sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath) contains a<br>PEEK (polyetheretherketone) hypotube for<br>flexibility. Rigid sheath (LUMINELLE DTx 360° Rotatable Disposable Sheath Rigid and<br>LUMINELLE Dx 360° Rotatable Disposable<br>Sheath (Diagnostic)) contains a 304 stainless<br>steel inner tube for rigidity | The LUMINELLE DTx System<br>is substantially equivalent to the<br>primary predicate, LUMINELLE<br>DTx Hysteroscopy System<br>(K192278), as they both contain<br>rigid and flexible sheaths.…